Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluore…

EUDAMED

Class IVD General (EU MDR)

Ref S3218E-48Ref S3334E-12-PRef S3334E-24

by Sansure Biotech Inc.

Identity

Device Name: Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) EUDAMED
Model / Reference: S3218E-48 EUDAMED
S3334E-12-P EUDAMED
S3334E-24 EUDAMED

Identifiers

Primary DI / UDI-DI: 06955792735323 EUDAMED
06955792731257 EUDAMED
06955792731233 EUDAMED
Basic UDI-DI: B-06955792735323 EUDAMED
B-06955792731257 EUDAMED
B-06955792731233 EUDAMED
EMDN Code: W0105070399 MULTIPLE VIRUSES - MULTIPLEX ASSAYS - OTHER EUDAMED
W0105040501 ADENOVIRUS - NA REAGENTS EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Astrovirus/Sapovirus/Enteric Adenovirus Nucleic Acid Diagnostic Kit (PCR-Fluore… by Sansure Biotech Inc. — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-06955792735323	Class IVD General	Active

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Manufacturer

Manufacturer: Sansure Biotech Inc.
EUDAMED SRN: CN-MF-000011392
Authorised Representative: Obelis s.a. BE-AR-000000106

Sources (3)

EUDAMED 5dbf6ae9-b262-469a-b1e2-1541f0c5c0d5 61 fields · synced Oct 6, 2026
EUDAMED e1f0de16-0c23-47ab-92b1-8e7625af57a5 61 fields · synced May 18, 2026
EUDAMED 7202bc84-296e-4ac0-ac8a-57f60f498130 61 fields · synced May 19, 2026